Wednesday, November 27, 2013

Natasha Singer in the New York Times:http://www.nytimes.com/2013/11/24/business/selling-that-new-man-feeling.html
--writes about the campaign to convince all men over the age of maybe 25 that if they ever once felt tired or run-down or in any way lacking in manly vigor, they probably have testosterone deficiency and need one of the various products to supplement their testosterone--now a $2B annual industry. It seems that the brilliance of deciding that testosterone deficiency should be called "low T" was a major breakthrough in the public acceptability of this new supposed disease state. Two executives from AbbVie, the maker of AndroGel, were named by the trade magazine Medical Marketing & Media as "the all-star large pharma marketing team of the year" for their low-T promotional campaign.

Singer makes two major points in her article--first, that Pharma has successfully skated around the FDA by pushing the idea of "low T" through unbranded promotions. If you run an ad telling the public that low T is real and serious and they should see their doctors to find out if they have it, but don't at the same time mention your drug by name, you can get away with pushing your drug for all sorts of conditions for which it has not been granted FDA approval. (The FDA, it seems, is quite old-fashioned and still thinks that testosterone replacement products should be used for medically diagnosed cases of significant hormonal deficiency.) The second point is the widespread use of questionnaires where virtually anyone will answer "yes" to at least one question, which is then supposed to suggest that you probably have low T and could benefit from treatment.

Singer mentions along the way that the risks of taking testosterone long-term when you don't have serious hormone deficiency are essentially unknown. So why does "low T" sound like the next Vioxx waiting to happen, where drug firms convince the entire world that they all need to take a drug, and only later find out the substantial increase in adverse reactions that they have now inflicted on thousands if not millions of people? (This is what a while ago Don Light and I labeled the "Inverse Benefit Law":http://brodyhooked.blogspot.com/2011/01/inverse-benefit-law-making-sense-of-how.html).

In a long post, Dr. Poses adds two important things to my
earlier comments. First, he drills down a good deal into why the new risk
calculator attached to the guidelines is flawed and premature. Second, courtesy
the Pharmalot blog, he fills in more details about conflicts of interest among
the guideline panelists, showing that I was too optimistic when I stated that
COI was at least somewhat kept under control or at least acknowledged more.
(For example, it’s nice, according to the IOM guidelines for writing good
guidelines, that the chair of the panel had no financial ties to industry. But
does it matter that in order to become guideline chair, he had to divest
himself of a whole pile of financial ties that he previously enjoyed?
Divestment: good; lots of things that needed to be divested: perhaps not so good.)

Nevertheless, while more details are being filled in, it is
still challenging to keep the big picture in view. The media accounts I’m
seeing in the newspapers seem calculated to reassure patients that it only
appears that the cardiology crowd is in disarray over the guidelines; actually
everything is just fine, so if your doc says to take a statin, you should have
full confidence that it’s good advice. In short, if the drug industry could
have written the script, it would be saying what most people are now saying.

So to restore a sense of perspective, let me go back to a
theme I have tried to raise on a number of occasions, for example:

The old narrative, that has led to so many millions of
Americans being placed on statin therapy, at great cost and at huge risk of
serious side effects, is: if your bad cholesterol is high, you’re at greater
risk for heart disease and stroke. Statins lower your bad cholesterol. So you
need to go to the doc, get a blood test to check your cholesterol, and if it’s
an eentsy bit high, start taking statins for the rest of your life.

If you carefully ask the right questions of the research
that’s been done in recent years, you learn that there is a shrinking amount of
evidence that supports this narrative, and a lot that says it’s in fact just
plain wrong. To the extent that statins reduce your risk of future bad stuff,
as they seem to, a little, in people with existing heart disease, there’s now
many reasons to believe that they don’t do it by lowering
cholesterol in the blood. The new guidelines, as I said in my previous
post, sort-of-kind-of admit this by eliminating the need to check cholesterol
levels routinely and the idea of target levels of cholesterol to shoot for.

So if the guidelines were true to the evidence, what message
would emerge? The message would certainly be: the grounds on which we used to prescribe
statins were all wet; there are a bunch of folks now taking statins who
probably don’t need them; we need to be much more refined in selecting the
smaller subsets of people who might actually benefit from taking
statins.

What message is actually being disseminated? It seems to be:
If you took statins under the old guidelines, have faith and keep taking them.
If you were not on statins previously, don’t worry, because our new, flawed
risk calculator will probably say that you too need to be on statins.

As I said, if the drug industry had been allowed to write
the script for this, it would have said exactly the same thing.

For some time, my colleague in bioethics, Dr. Carl Elliott, at U-Minn, was alone in pressing for a full investigation of this case that led to a young man committing suicide while enrolled in a university-conducted, industry-sponsored clinical trial of psychiatric drugs, when his mental state would have appeared to preclude the possibility of his giving proper informed consent to participate in the trial. More recently, however, as a recent piece in Minnpost summarizes:http://www.minnpost.com/second-opinion/2013/11/u-m-bioethicist-latest-call-independent-look-schools-troubling-markingson-cas
--Dr. Elliott has been joined by his U-Minn colleague in bioethics, Dr. Leigh Turner, and also by Dr. Trudo Lemmons at the University of Toronto, in approaching the University administration and demanding a thorough investigation and accounting. (Full disclosure: I am a signatory to the petition that Dr. Lemmons circulated.)

You might wonder why I continue to call attention to this case, which the University insists is old news, was previously investigated and they were found blameless, and these are just malcontents trying to stir up trouble. Besides all the important ethical issues about the ethical conduct of research and informed consent and protection for psychiatric patients, there is what happens when a University decides to get into bed with Pharma and accept big research grants--and then to decide that the faculty who attract those grants, by doing Pharma's bidding, are their best faculty and should be properly rewarded for the largesse they are bringing in. There is further the question of what happens when something ethically questionable is alleged in one of these studies; and whether the University will then remember that it is supposed to be about good science and about the public interest, or whether the instinct of self-preservation takes over and the response is stonewalling and obfuscation.

Dr. Turner in the Minnpost interview is commendably noncommittal over whether any actual wrongdoing occurred, and in calling solely for more information to be disclosed. I would say that enough is known so far to show that Drs. Elliott, Turner, and Lemmons are fully justified in demanding more answers and in saying that the so-called investigations that have taken place so far are woefully inadequate. People who really care about the reputation of the University of Minnesota would be listening to them rather than continuing to attack them.

Now, the price of drugs, and generic prescribing, is not a hot topic on this blog, so the main thing I wanted to point out is one fact from the article. The authors note that a relatively small number of Medicare prescribers are responsible for a hugely disproportionate excess of brand-name prescriptions and hence unnecessarily high costs. They then proceeded to check out their Dollars for Docs tool and noted that these same docs also seemed disproportionately represented among those receiving payments from drug companies. When ProPublica reporters visited some of the offices of these docs, they could hardly get in the door for all the drug reps waiting in line to handout free samples and other goodies.

As was nicely summarized in the excellent review article by Spurling and company from Healthy Skepticism:http://brodyhooked.blogspot.com/2010/10/major-new-study-published-in-plos.html
--all the available evidence shows that taking money and information from the drug companies is associated with irrational prescribing and more expensive prescribing. I can think of few things more irrational than routinely prescribing brand-name drugs when a generic equivalent is available; and that certainly leads to higher costs.

I had been holding off on commenting on the cholesterol
treatment guidelines recently issued by the American Heart Association and the
American College of Cardiology:http://circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437738.63853.7a
--because I know that many of the friends that I have
previously quoted here, the thoughtful naysayers in the put-everybody-on-statins
campaign, were sharpening their statistical knives to go after the new
document, and I hoped to be able to link to a truly scholarly dissection of the
issue.

I am perhaps jumping the gun a bit egged on by today’s All Things Considered on NPR, which had
a lead story on the critics of the risk calculator that’s part of the
guidelines, a debate that apparently blew up at the Heart Association’s big
annual meeting. So with apologies for my own inability to drill down with any
statistical acumen, I will offer a preliminary read.

If you just looked at the guidelines quickly, you’d say that
the guideline writers had had a sudden attack of brilliance. Some of the basic
points that this blog has been carping on for several years now are reflected in
the document:

Treatment with statins
should be based on the patient’s heart-disease-stroke risk level and not
on a blood level of cholesterol.

There’s no evidence that
shooting for any specific target level of cholesterol is better than
simply placing the patient on a reasonable dose of a statin and keeping
them there.

Not only that, but the guideline panel seems actually to
have taken on board some of the criticisms of conflicts of interest. The chair
of the panel reports no conflicts, and while a few of the panelists have
seriously long lists of industry funding, many do not. And there’s quite
detailed disclosure. (I admit that I did not check to see if any of the people
reporting no COI actually could be found to be on the industry payroll.)

So—what’s not to like? Well, a number of things. What the
panel giveth, they then taketh away, usually in the fine print of the document.

The panel realizes that there’s no good evidence to
recommend a particular target level of cholesterol. But they are impressed (as
we’ll see) with the studies that show that lower LDL cholesterol is associated
with lower risk. They then urge the physician to prescribe a “moderate” or a
“high” intensity dose of their favorite statin, with the idea that the end
result will be a certain percentage drop in the LDL level—with the additional
proviso that if you don’t achieve that level of drop, you will need to up the
dose. So the idea of treating to a target level went out the front door and
snuck back in the rear window.

Where did this panel get the idea that you need to reduce
LDL by a certain percentage? Well, it turns out that they were quite enamored
of one particular study, the CTT meta-analysis in Lancet in 2012. I tried to explain at some length:

http://brodyhooked.blogspot.com/2012/05/statins-in-water-supply-continued-why.html
--why that study was deeply flawed because it answered the
wrong question. Moreover, that was not an independent clinical trial; it was a
re-analysis of data from many previous trials, and when analyzed by people who
are not on the statin bandwagon, all those previous trials yielded much less
optimistic results in favor of prescribing statins. Yet if you look at the
evidence table that the current panel relies on, “CTT” jumps off the page at
every turn.

Next we come to the point that NPR addressed today—the risk
calculator. If you no longer treat with statins based on level of blood LDL,
but based on the patient’s level of risk, then it becomes critical that you
have a reliable measure of that risk. The critics are shouting today that the
calculator that the panel favors way overestimates heart-disease risk. Before I
get into that discussion I will wait to see one figure that I think is
critical—how many additional people will be prescribed statins in the US based
on this risk calculator? There are no doubt some people that could benefit from
statins who are not now getting them. But there are a whole bunch more IMHO who
are currently on statins because their blood tests looked bad and yet they have
no diagnosed heart disease and are at reasonably low risk. So if the calculator
leads to a net increase in statin prescribing, we know it has to be a move in
the wrong direction.

But wait, as those TV ads say, there’s more. Two things are
almost completely absent from these guidelines, that ought to be front and
center in any practical approach to evidence-based prescribing of statins
today. First is the concept of NNT. I didn’t see anywhere where the guidelines
stated an actual NNT. The assumption is that if a study shows that statins
offer any benefit for any particular group, then you should prescribe the
statin—never mind if you have to give a statin to 400 people to prevent 1
cardiovascular event. (If you had an NNT, then you could talk further about
shared decision making, giving the patient the facts and letting them decide if
they wanted a statin—another concept curiously lacking from these guidelines.)
Finally, what’s massively missing is any significant discussion of the downside
of statins. According to these guidelines, a vanishingly small number of
patients have any serious side effects. The possibility, for example, that as
many as half of all patients on statins have some muscle aches or weakness, or
the emerging worry that dementia may be more common in statin users, gets no
mention whatsoever.

Bottom line—it looks worrisomely like what I concluded with CTT—even if
these guidelines were not written by people in the pay of the drug industry,
they could just as well have been. And somehow, while important new evidence
against the routine use of statins, and suggesting that we really don’t know
much about the true mechanism by which these drugs work in the cases where they
do, crept into the guidelines for the first time, the bottom line is largely
unaffected by such enlightened thoughts. We’re back to putting statins in the
water supply.

NOTE ADDED 11/20: I can now cite a comment by some real experts, Drs. John Abramson and Rita Redberg, in the New York Times: http://www.nytimes.com/2013/11/14/opinion/dont-give-more-patients-statins.html?_r=0
These two estimate that the new guidelines would increase the number of people considered candidates for statin therapy by 70 percent, with 18 percent of these at risk for the adverse effects of statins, with no evidence of fewer deaths from heart disease or stroke as a result. (They mention what most statin advocates ignore, that even the most successful clinical trials tend to show that statins reduce the risk of heart attack or stroke, but still have no impact on overall mortality.)

Saturday, November 16, 2013

I have been mulling over several new posts, including one on the recently issued cholesterol treatment guidelines, and have come to the realization that underlying all of the messages I most want to convey is one basic point.

So the worrisome bottom line is that all this time, as we have been sold a bill of goods from the drug industry about how if we do one single thing to get in the way of their excessive profiteering, we'll suffer a screeching halt to medical progress, we have ignored the fact that the real "progress" in recent years is how many prescription drugs the average American is already taking and the harm done to them in terms of both mortality and morbidity from this over-drugging.

My friends in the evidence-based medicine movement have tried to chip away at this industry brainwashing particularly by attacking the commonly heard phrase "risk-benefit ratio." They point out quite reasonably that this term, which seems totally objective on the surface, actually hides a serious bias. We talk about "benefits" as if they were assured (no "risk" of benefit) but we only allude to harm as something that might or might not happen. The EBM gurus now say that we should always be precise and talk about the "harm-benefit ratio," unless we want to get really wordy and talk about the "probability of harm-probability of benefit ratio."

This leads me to one of my periodic modest proposals. I suggest, in light of the recent epidemiologic evidence, that we should now begin to talk about the "harm-hope ratio." I propose this term because:

As above we have solid epidemiologic evidence that the American public is killing ourselves by ingesting way too many prescription drugs.

When we do the usual studies, we are generally shocked by the high number-needed-to-treat (NNT) attached to commonly used drugs. The really great drugs like metformin for Type 2 diabetes usually run an NNT of around 10-30--that is, 10 to 30 patients have to take the drug for a certain length of time to achieve the hoped-for therapeutic benefit. The crappy drugs like statins for primary prevention of heart disease run NNT's typically in the several hundreds.

Therefore, the usual situation when we take prescription drugs--we can be almost certain that at least on the population level, harm is being caused; and we accept the harm given our hope that we might be the lucky soul who's the 1 out of 30, or the 1 out of 400, who will actually derive some significant therapeutic benefit, like not dying of a heart attack in the next few years.

Maybe if we were more honest and started talking widely about the harm-hope ratio, instead of the highly misleading risk-benefit ratio, we'd start to turn the proverbial ocean liner around.

Let's return to our standard form for such matters:Company: Johnson & JohnsonDrugs involved: Risperdal, Natrecor, InvegaAllegations: Off label marketing, kickbacksAmount of settlement: $2.2BSettlement equals what percent of annual drug sales: Approximately 87% as best as I can estimate for all 3 drugs, making this one of the heftier settlements on recordDid company admit guilt? Supposedly J&J admitted "accountability" but not wrongdoing, whatever that means

In what appears now to be the formulaic response to any such settlement, J&J spokespeople deny that the company is guilty of any wrongdoing, but say that the settlement was paid simply so that the company can move on and put this unpleasantness behind them. I can sort of understand this; if you paid me $2.2B, I can imagine a good deal of moving on that I would be able to accomplish, and I would certainly put a lot of unpleasantness behind me.

Dr. Roy Poses, as usual, noted that magically, J&J managed to do this bad stuff without any individual human being doing anything wrong and requiring punishment, and opines that until individuals start doing jail time, we should not expect any changes in industry behavior. For a confirming opinion, recall our recent post:http://brodyhooked.blogspot.com/2013/11/deadly-medicines-over-top-or-overdue.html
--and the quote therein: “I dedicate this book to the many honest people working in the drug industry who are equally appalled as I am about the repetitive criminal actions of their superiors and their harmful consequences for the patients and our national economies. Some of these insiders have told me they would wish their top bosses were sent to jail, as the threat of this is the only thing that might deter them from continuing committing crimes.”

Sunday, November 10, 2013

Once again I'm indebted to my friends Rick Bukata and Jerry Hoffman at Primary Care Medical Abstracts for pointing out papers that I missed when first published in the last 6 months or so (subscriptions may be required to access articles).

First off is a review by authors from London, Australia, and Stanford U. (the latter being our old pal John Ioannidis). Nothing really new here for regular readers of this blog, but the article is a nice update on the most compelling recent evidence for the various ways that undue industry influence distorts medicine. Those wanting to be sure to cite the most recent and comprehensive evidence will want to have this handy.

Next is a study out of UCSF, co-authored by Lisa Bero, another name familiar to our regular readers. At question here is what conflict-of-interest guidelines govern the activities of the 51 state Medicaid boards that decide what drugs should be covered by these tax-supported plans for low-income patients. The authors were able at first to get only 14 of these guidelines off websites or other easily available sources, and by further correspondence and begging and pleading they eventually got a total of 27 guidelines. Only 4 of the 27 guidelines seemed really strict on banning COI with industry, and in many cases they were told that the guidelines are not for public disclosure. Excuse me? A taxpayer-supported public program, and the guidelines to govern COI are secret??? What the heck is going on here? The overall situation is obviously highly unsatisfactory.

Sunday, November 3, 2013

I have blogged in the past--http://brodyhooked.blogspot.com/2010/06/more-on-trial-registries-any-impact-on.html
--about the hope that mandatory registration of clinical trials would end some of the lack of transparency that currently surrounds industry-sponsored drug studies. In general, the previous studies indicated a lot of problems despite the registry, including frequent changes in study end-points, for example.

The BMJ recently published a new study:http://www.bmj.com/content/347/bmj.f6104
--by a group primarily based at University of North Carolina, that looked only at one outcome--how likely was a trial that included at least 500 subjects to publish results within about 4 years of completion? Note that they did not look at whether anyone juggled the trial design or methods, just whether any results at all were published in peer-reviewed journals or on the registry website itself. The authors chose only large studies because they judged that common excuses for non-publication--we got too busy; or we submitted and the editors rejected the manuscript--would be much less likely to hold for trials of this size.

Basically the authors found that 29% of these large trials remained unpublished. Of that 29%, an additional 22% had some results available through the trial registry itself. The authors commented that this latter is not an optimal result, as the journal peer review process is presumably valuable for identifying possible flaws and gaps in study methods. Industry-sponsored studies were more likely than others not to be published (32% vs. 18%). Put another way, industry-sponsored trials accounted for 88% of all the unpublished trials.

The present authors highlight an ethical concern that I mentioned in HOOKED. When people volunteer as subjects in a research trial, they believe that they are doing something in the service of science. If the results of the trial are never published, their "contract" with the investigator is thereby violated. Hence investigators have an ethical duty to do their best to publish research results, quite apart from whatever other obligations they may also be under.

This study, as noted, merely looked at whether any results were published in peer-reviewed journals; they did not ask whether the methods reported in the final paper matched what had been entered into the registry. So we still could have had, among the trials that were published, cases of industry-sponsored trials changing the endpoints or otherwise adding unscientific spin to make the company's drug look better, as noted in previous research. In short, the present study probably underreports by a considerable extent the continuing problems with the commercial control over pharmaceutical research. Even so, it highlights the fact that merely creating a mandatory trials registry has been far from solving the basic problem.

Friday, November 1, 2013

I began writing this post from Atlanta where I was (as usual
this time of year) attending the annual meeting of the American Society for
Bioethics and Humanities. In past years there has been maybe one session per
year on something directly related to Pharma issues, so I was impressed to see
at least three sessions on this year’s program. Here I report on a panel,
“Bioethics Capacity Building in a Corporate Setting: One Pharmaceutical
Company’s Experience,” presented by two folks from Eli Lilly and two
distinguished academic bioethicists who have served for 15 years on the
company’s bioethics advisory panel. The panel moderator was Luann E. Van Campen,
PhD, head of the Bioethics Program at Lilly, and one of the panelists was
Donald G. Therasse, MD, VP for Global Patient Safety and Bioethics at the firm,
to whom Dr. Van Campen reports.

The two academic bioethicists on the panel were indeed heavy
hitters—Tom Beauchamp, PhD of the Kennedy Institute of Ethics at Georgetown,
co-author of what most regard as the canonical textbook in the field, Principles of Biomedical Ethics; and
Robert Levine, MD, of Yale.I’ll focus
mostly on what Dr. Beauchamp said as Dr. Levine indicated he endorsed almost
all the former’s comments.

The academics reminded us that the bioethics advisory board
at Lilly has so far concentrated its work in only one area—the ethics of
research on human subjects. (The case study Dr. Levine discussed had to do with
clinical trials in a poor country of a drug that might then be unaffordable to
the population of that country.) Organizational or business ethics related to
Lilly as a corporation was simply not on the agenda. Therefore, the academics
said, apparently with justification, that they saw very little difference
between being a paid consultant for Lilly and consulting on any bioethics body
within their own university or in the academic world.

In response to an audience question, Dr. Therasse made an
interesting comment. He said that perhaps in a few years, the bioethics program
at Lilly would branch out and start to address these wider ethical issues.
However, Lilly right now, like many of the large drug firms, is under a
corporate integrity agreement with the U.S. Department of Justice. Until that
agreement expires, the staff people who might work on that wider ethical
inquiry have their hands completely full doing all the required compliance
tasks with the corporate integrity. When the agreement expires, those people
will presumably be freed up.

Dr. Therasse did not tell the audience what the corporate
integrity agreement was triggered by, so I can’t be sure that it relates to
this previous post:

http://brodyhooked.blogspot.com/2009/01/lilly-fine-for-zyprexa-off-label.htmlBut consider what’s apparently being said. Lilly was forced
by a legal settlement to improve its corporate ethics behavior. They now say
that they don’t have enough staff to attend to a full bioethical inquiry into
their company’s activities because they are too busy complying with that
settlement. But as soon as the settlement ends, then they can take the time and
trouble to think more about ethics. Everybody got that? (I’m pretty sure that
Lilly monitors this blog, so if I’ve been unfair to you guys, tell me, OK?)

My main concern, however, was not with Lilly but with my
academic bioethics colleagues. Dr. Beauchamp began his talk by noting that some
in our field criticize him for consorting with industry in this fashion. He
then characterized their criticism using a series of straw-man arguments, such
as they thought it was bad to make profits. He failed to address a single
substantive argument made against close relations with Pharma based on actual
patterns of industry behavior. So far as Beauchamp was concerned, there simply
was all upside and no downside to consulting with drug firms. We recently reviewed
the new book by Peter Gøtzsche that was highly critical of the industry:

What was embarrassing about this presentation was that if a
physician/scientist had given such a talk, explaining why he was a paid
consultant to Eli Lilly, anyone with any familiarity with the industry would
have labeled the talk as the typical rationalization that people with their
hands in the till give when in denial of their actual conflict of interest. Here
we have one of the bright lights of the field of bioethics imagining that he is
giving a presentation that defends his role as a paid industry consultant,
apparently not even realizing that he is merely giving that much more
ammunition to critics of current financial entanglements.

To elaborate further on a theme that I have
stressed repeatedly here, I want to contrast the positions of my academic
colleagues with that of Dr. Van Campen. I may agree or I may disagree with her
ethical thinking on a variety of issues, but at least we know fully where her
loyalties lie. She’s a paid Lilly employee, and we must imagine that the minute
that her activities were judged by Lilly to be bad for business, she’d be out
the door. My concern rather is for people like me who imagine that we are
independent, objective scholars, but that we can accept a role as a paid
consultant to Lilly or any similar company while still adhering with full
integrity to our independent stance. This panel, if anything, further
demonstrated the fallacy of that view.

The book features Forewords by two heavy hitters, Richard Smith,
former editor of BMJ, and Drummond
Rennie, long-time deputy editor of JAMA.
If you read between the lines, the two editors both convey more or less the
same message—this guy comes across as a raving lunatic, but it would be a shame
if you were put off by that tone, because he actually has something important
to say.

By way of the lunacy quotient, I append a representative
list of quotes:

“In the United States and
Europe, drugs are the third leading cause of death after heart disease and
cancer.”(1)

“The main reason we take so
many drugs is that drug companies don’t sell drugs, they sell lies about
drugs. Blatant lies that—in all the cases I have studied—have continued
after the statements were proven wrong.”(2)

“The book addresses a
general system failure caused by widespread crime, corruption and impotent
drug regulation in need of radical reforms. Some readers will find my book
one-sided and polemic, but there is little point in describing what goes
well in a system that is out of control. If a criminologist undertakes a
study of muggers, no one expects a ‘balanced’ account mentioning that many
muggers are good family men.”(2)

“I dedicate this book to the
many honest people working in the drug industry who are equally appalled
as I am about the repetitive criminal actions of their superiors and their
harmful consequences for the patients and our national economies. Some of
these insiders have told me they would wish their top bosses were sent to
jail, as the threat of this is the only thing that might deter them from
continuing committing crimes.”(3)

“[Industry] clinical trials
are rarely research in the true sense of the word…it is marketing
disguised as research. The trials are often flawed by design, additional
flaws are introduced during data analysis, and the misleading results are
spun to make sure that whatever an honest trial might have shown, the
trial concludes something that is useful for boosting sales.”(87)

“We should ask our
politicians to forbid marketing of drugs, as it is harmful, just like
marketing of tobacco is, which is why we have prohibited tobacco
advertisements…. There is no need for drug marketing, as the products
should speak for themselves.”(94, 275)

“Anyone of us will need to
consider the pros and cons of taking a drug, and our doctor isn’t always
the best person to ask, as most doctors have been brainwashed and many
have been bribed by the drug industry.”(129)

“We cannot trust industry
trials at all and the reason is simple. We don’t trust a person who has
lied to us repeatedly, even though that person may tell the truth
sometimes.”(265)

Throughout the book, Gøtzsche uses the organized crime motif
to characterize the drug industry. This is quite deliberate and measured. He
argues that something counts as organized crime when:

They kill people

They lie about what they
do

They routinely break the
law as a part of their business practices

They use their ill-gotten
gains to corrupt the government regulatory apparatus so as to be allowed
to continue to operate

Gøtzsche is a physician, epidemiologist and research
methodologist, and has achieved prominence as head of the Nordic Cochrane
Center, a part of the Cochrane Collaboration which is generally recognized as
the most reliable and independent assessor of medical data—a sort of gold
standard if you want to know: how good is the evidence that any treatment works
for any disease? So this guy is not one to fly off the handle and make charges
that he cannot document with solid evidence. (I give him some credit for solid
evidence since he several times cites HOOKED.)I have not always agreed with Gøtzsche in the past—he’s co-author of a
widely cited meta-analysis in the New
England Journal (2001) purporting to show that the placebo effect, one of
my own pet research interests, probably doesn’t exist. But while some of the
evidence he brings forward in this volume is new to me, and much is worth
reading simply to get the European perspective on the issue, very little of
what he says would be of any real surprise to anyone who has read HOOKED and/or
kept up with this blog.

In a minor way, the evolution of this blog parallels what
Gøtzsche is up to. If you take the trouble to go back and look (I don’t advise
it), check out how long it took me to use the actual words bribery and corruption
in describing Pharma behavior. I now use those words unabashedly because I am
quite secure in knowing that the behavior is accurately described by such
terms, and there is no point in pussyfooting around the real and serious
problem the behavior poses. If we get overly obsessive about not appearing
intemperate, we pay the price of failing to endorse the really basic and
drastic reforms that are needed to clean up the current mess.